A Clinical Evaluation of an Esterified Hyaluronic Acid Matrix on Preparing Wounds in Burn Patients for Split-thickness Skin Grafting
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 主要终点
- Number of Days From Initial Application of Wound Matrix to Approval of Wound to Receive a Split Thickness Skin Graft
研究概览
简要总结
Burn patients meeting inclusion criteria will receive the esterified hyaluronic acid matrix as the matrix for their wound, in conjunction with the standard of care for managing these types of wounds. The study will be divided into two phases. Phase I will entail intervention with the wound matrix and will continue until one of the following occur, sufficient granulation has occurred and the patient can receive a STSG and proceed to Phase II, the patient's physician determines an STSG is no longer necessary or two applications with the wound matrix occur and no STSG is approved. Phase II will begin following the STSG procedure. In this phase, the wound will be monitored and proportion of STSG take will be evaluated but no application of the wound matrix device will take place. This phase will continue for 28 days or if the physician deems the patient no longer needs regular care to monitor the wound, whichever occurs earlier.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has a wound originating from a thermal or electrical burn
- •Target burn area is less than 20% of TBSA
- •Target burn wound is greater than 0.5% of TBSA
- •Patient has undergone escharectomy procedure or will undergo escharectomy on the target burn and resulting wound will likely need a split thickness skin graft, but wound site is not immediately ready for grafting
- •For patients with diabetes, an A1C hemoglobin level between 11 percent (taken within 90 days)
排除标准
- •Current active diagnosis of substance abuse, per the Investigator
- •Patient currently taking non-inhaled corticosteroids
- •Patient needs or is likely to need negative pressure wound therapy of the target wound after application of Hyalomatrix Wound Device
- •Patient is pregnant, planning to become pregnant during study period, or breastfeeding
- •Unstable medical condition as determined by the site investigator
- •Patients with known sensitivities to hyaluronan, hyaluronan derivatives, silicone, or any other ingredients of the Hyalomatrix Wound Device
研究组 & 干预措施
Esterified hyaluronic acid matrix
干预措施: Esterified Hyaluronic Acid Matrix (Device)
结局指标
主要结局
Number of Days From Initial Application of Wound Matrix to Approval of Wound to Receive a Split Thickness Skin Graft
时间窗: Baseline to 42 days
次要结局
- Patient Pain Rating(Baseline to 42 days)
- Change in Wound Volume From the Time Prior to Application of the Wound Device to the Time Before the Application of STSG and After STSG(Baseline to 42 days)
- Proportion of Split Thickness Skin Graft Take for the Wound at 28 Days(28 days)
- Length of Stay in Inpatient Unit(Baseline to 42 days)
- Subject Discharge Destination(Baseline to 70 days)
- Proportion of Patients Who Develop an Infection of the Target Wound at Any Time Per Confirmation With Culture(Baseline to 70 days)